JP7414823B2 - Biological fluid collection system and stabilization assembly - Google Patents

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application Serial No. 62/719,166, filed August 17, 2018, entitled "Biological Fluid Collection System and Stabilization Assembly." , the entire disclosure of which is incorporated herein by reference.

TECHNICAL FIELD This disclosure generally relates to biological fluid collection systems. More specifically, the present disclosure provides a method for collecting a small sample of blood and distributing a portion of the sample to a device for analyzing the sample, such as a point-of-care or near-patient testing device. The present invention relates to a collection device for collecting an arterial blood sample that is sent to a collection module and a blood gas analyzer.

There is a need for a device that allows for the collection of microsamples, such as samples of less than 1.0 milliliter, collected for analysis, for use in patient consultation settings and blood gas analysis applications. Current devices require traditional sample collection and subsequent transfer of a small blood sample using a large syringe or pipette to a point-of-care cartridge or device receiving port. Such an open system approach not only increases the risk of blood exposure to personnel performing the test, but also results in the collection of excess specimens needed for a particular test procedure.

Therefore, to have a means of collecting and dispensing blood samples for point-of-care gas analysis applications that incorporates traditional automated blood collection and includes novel controlled sample transfer capabilities while minimizing exposure risk. is desirable.

There is also a need to reduce the number of workflow steps in arterial blood gas collection procedures.

US Patent Publication No. 2016/262679 US Patent Publication No. 2019/265134 US Patent Publication No. 2005/0187493 International Publication No. 2019/204147

Venous and arterial blood samples, including a collection module for collecting a small sample of blood and distributing a portion of the sample to a device for analyzing the sample, such as a laboratory device for point of care or near the patient. A biological fluid collection system, such as a blood collection device, for collecting biological fluids is disclosed.

According to one embodiment of the invention, a biological fluid collection system includes a collection module configured to receive a sample, the housing having an inlet and an outlet in body fluid communication, and a cannula. a mixing chamber disposed between the inlet and the outlet; and a collection chamber disposed between the mixing chamber and the outlet, the actuation section including a first section in which a sample is receivable within the collection chamber. a collection chamber that is movable between a first position and a second position in which a portion of the sample is ejected from the collection chamber; a collection module that engages a portion of the housing and a portion of a cannula; a safety shield that is movable from a first position in which the cannula is exposed to a second position in which the cannula is shielded by at least a portion of the safety shield.

According to another embodiment of the invention, a biological fluid collection system includes a collection module configured to receive a sample, the housing having an inlet and an outlet in body fluid communication, and a cannula. , a mixing chamber disposed between the inlet and the outlet, and a collection chamber disposed between the mixing chamber and the outlet, the actuation portion including a sample being receivable within the collection chamber. a collection module including a collection chamber that is transitionable between a first position and a second position in which a portion of the sample is ejected from the collection chamber; a tube holder and a wingset in communication with the tube holder, the tube holder being engageable.

According to another embodiment of the invention, a body fluid collection cartridge configured for use with a needle holder for collecting a body fluid sample has a proximal end, an open distal end, and a proximal end and a distal end. a tubular member having a sidewall extending between ends thereof and defining an interior chamber having an interior container; and a penetrable closure associated with an open distal end of the tubular member, the sidewall of the tubular member. a plunger configured to cooperate with the closure portion to sealingly close the open distal end; a stopper; and a plunger rod removably associated with each other by an interengaging configuration with the stopper. A rod assembly, wherein the interengaging configuration allows the plunger rod to apply a distal force to the stopper, and the plunger rod from the stopper and the tubular member when a proximal force is applied. a plunger rod assembly configured to allow removal of the plunger rod assembly, and a shieldable needle device.

The disclosed device has the following advantages over conventional arterial blood gas (ABG) collection kits. (1) Ergonomic design with designated touch points. (2) Thin-walled needle technology that allows for smaller standard needles while maintaining high flow rates that result in shorter filling times. (3) A push-button safety shield that does not obstruct the user's view during the procedure and can be activated with one hand by simply pressing a button after collection. (4) Integrated vent/vent cap feature that can remove trapped air bubbles by easily draining during filling or after collection. and (5) use of a safety sleeve with a guard and push button to prevent accidental activation of the safety shield during transportation of the device.

These and other features and advantages of the disclosure, as well as methods of achieving them, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure in conjunction with the accompanying drawings. There will be.

FIG. 1 is a perspective view of a biological fluid collection system according to another embodiment of the invention. FIG. 2 is a side cross-sectional view of a collection module with a cap according to an embodiment of the invention. FIG. 3 is a side cross-sectional view of a collection module with the deformable portion in an initial position, according to an embodiment of the invention. FIG. 4 is a side cross-sectional elevational view of a biological fluid collection system with a fixation device in a fixed position, according to an embodiment of the invention. FIG. 5 is a side cross-sectional elevational view of a biological fluid collection system with a fixation device in an unlocked position, according to an embodiment of the invention. FIG. 6 is a cross-sectional perspective view of an acquisition module with a deformable portion in an initial position adjacent to a point-of-care testing device in accordance with an embodiment of the invention. FIG. 7 is a cross-sectional perspective view of an acquisition module with a deformable portion in a deformed position adjacent to a point-of-care testing device in accordance with an embodiment of the invention. FIG. 8 is a perspective view of a collection module according to an embodiment of the invention. FIG. 9 is an exploded perspective view of a needle assembly with a hinged safety shield, according to an embodiment of the invention. 10 is a perspective view of the assembled needle assembly of FIG. 9 in a retracted position; FIG. FIG. 11 is a side cross-sectional view of the needle assembly of FIG. 10. FIG. 12 is a perspective view of the needle assembly of FIG. 10 in an extended position. FIG. 13 is a perspective view of a biological fluid collection system according to another embodiment of the invention. FIG. 14 is a perspective view of a biological fluid collection device inserted into a tube holder, according to an embodiment of the invention. FIG. 15 is a perspective view of a body fluid collection system according to another embodiment of the invention. FIG. 16 is a perspective view of components of a body fluid collection assembly according to an embodiment of the invention. FIG. 17 is a perspective view of a body fluid collection assembly according to an embodiment of the invention. FIG. 18 is a partial cross-sectional side view of a body fluid collection cartridge as also shown in FIG. 16, according to one embodiment of the invention. FIG. 19 is a cross-sectional side view of a body fluid collection assembly as shown in FIG. 18 during insertion of a body fluid collection cartridge into a holder, according to an embodiment of the invention. FIG. 20 is a cross-sectional side perspective view of a body fluid collection assembly as shown in FIG. 17 during insertion of a body fluid collection cartridge into a holder, according to an embodiment of the invention. FIG. 21 is a side cross-sectional perspective view of a body fluid collection assembly as shown in FIG. 17 after priming with a fluid treatment additive and prior to collection of a body fluid sample, according to an embodiment of the invention. FIG. 22 is a side cross-sectional view of a body fluid collection assembly as shown in FIG. 19 during removal of the plunger rod after priming with a fluid treatment additive, according to an embodiment of the invention. FIG. 23 is a perspective view of a body fluid collection assembly during body fluid collection, according to an embodiment of the invention. FIG. 24 is a side cross-sectional view of the body fluid collection assembly as shown in FIG. 23 upon completion of body fluid sample collection, according to an embodiment of the invention. FIG. 25 is a top view of a body fluid collection cartridge showing the direction of agitation after collection of a body fluid sample, according to an embodiment of the invention. FIG. 26 is a side cross-sectional view of a body fluid collection cartridge illustrating a post-collection mixing motion state of a body fluid sample, according to an embodiment of the present invention. FIG. 27 is a perspective side view of a body fluid collection cartridge with a Luer adapter in preparation for transport and testing, according to an embodiment of the invention. FIG. 28 is a perspective view of a blood collection set according to the present invention. FIG. 29 is a side view of the blood collection set showing the outer shield in a retracted position. FIG. 30 is a side view of the blood collection set showing the outer shield in an extended position.

Corresponding reference numbers indicate corresponding parts in the several figures. The examples presented herein indicate exemplary embodiments of the disclosure, and such illustrations should not be construed as limiting the scope of the disclosure in any way.

The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated to practice the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the invention.

For purposes of explanation, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "Horizontal", "vertical", and their derivatives refer to the invention as it is oriented in the drawings. It will be understood, however, that the invention may be susceptible to various alternative modifications, unless expressly specified to the contrary. It is also to be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. As such, specific dimensions and other physical characteristics associated with the embodiments disclosed herein are not to be considered limiting.

The present disclosure provides a power source for a collection module that receives a sample and provides flow-through blood stabilization technology and accurate sample dispensing capabilities for point-of-care testing and near-patient testing applications. A biological fluid collection system comprising: The collection module of the present disclosure can provide dispersive mixing of a sample stabilizer within a blood sample and dispense the stabilized sample in a controlled manner. In this way, the biofluid collection system of the present disclosure can be used for blood microsample management for point-of-care and near-patient testing applications, such as inert mixing with sample stabilizers and controlled enable distribution.

Advantageously, the biofluid collection system of the present disclosure is useful for point-of-care and near-patient testing applications, automated blood collection, inert mixing techniques, and point-of-care cartridges and near-patient testing. Provides a consistent blood sample management tool for controlled small volume sample dispensing capabilities to standard Luer interfaces with 2 inlets.

1-8 illustrate an exemplary embodiment of a biological fluid collection system 10 of the present disclosure configured to receive a biological fluid sample, such as a blood sample 12. FIG. In one embodiment, the biological fluid collection system 10 of the present disclosure includes a collection module 14 configured to receive a blood sample 12 and a power source 16 removably connectable to the collection module 14. The power source of the present disclosure includes a user-operated vacuum source for aspirating the biological fluid sample within the collection module 14. In one embodiment, collection module 14 includes a cannula 17 as part of which blood sample 12 is obtained at collection module 14 from a patient.

1-8, in one embodiment, a collection module 14 of the present disclosure is configured to receive a biological fluid sample, such as a blood sample 12, and includes a housing 20, a mixing chamber 22, a sample stabilizer 24, a collection It includes a chamber 26, a closure 28, and a cap 30.

In one embodiment, the housing 20 of the collection module 14 includes an inlet 32 and an outlet 34. Inlet 32 and outlet 34 are in fluid communication via a passageway 36 extending therebetween.

Mixing chamber 22 and collection chamber 26 are in fluid communication with passageway 36. The mixing chamber 22 and the collection chamber 26 are arranged such that a biological fluid sample, such as a blood sample 12, introduced into the inlet 32 of the collection module 14 first passes through the sample stabilizer 24, and then the blood sample 12 and the sample stabilizer The agent 24 passes through the mixing chamber 22 and then the sample 12 with the sample stabilizer 24 appropriately mixed flows into the collection chamber 26 before reaching the outlet 34 of the collection module 14 . In this manner, the blood sample 12 may have anticoagulant or other additives provided within the collection module 14 before passing through the mixing chamber 22 for proper mixing of the sample stabilizer 24 in the blood sample 12. The stabilized sample is then received and stored within a collection chamber 26.

In one embodiment, sample stabilizer 24 is disposed between inlet 32 and mixing chamber 22. Collection module 14 of the present disclosure provides inert and rapid mixing of blood sample 12 and sample stabilizer 24. For example, collection module 14 includes a mixing chamber that allows for inert mixing of blood sample 12 with an anticoagulant or other additive, such as a blood stabilizer, as blood sample 12 flows through mixing chamber 22. Contains 22.

A sample stabilizer can be an anticoagulant or a substance designed to preserve certain components in blood, such as RNA, protein analytes, or other components. In one embodiment, sample stabilizer 24 is disposed between inlet 32 and mixing chamber 22. In other embodiments, sample stabilizer 24 may be located in other areas within housing 20 of collection module 14.

Referring to FIGS. 2 and 3, in one embodiment, the collection module 14 includes a material 40 including pores 42 disposed between the inlet 32 and the mixing chamber 22, and a material 40 disposed between the inlet 32 and the mixing chamber 22. and dried anticoagulant powder. In this manner, collection module 14 may include a dry anticoagulant, such as heparin or EDTA, deposited on or in a portion of collection module 14. In one embodiment, the material 40 is an open cell foam containing a dry anticoagulant dispersed within the cells of the open cell foam, facilitating the effects of flow-through mixing and anticoagulant uptake. In one embodiment, sample stabilizer 24 is a dry anticoagulant powder.

In one embodiment, the open cell foam can be treated with an anticoagulant to form a dry anticoagulant powder that is finely dispersed throughout the pores of the open cell foam. As the blood sample 12 enters the collection module 14, it passes through the open cell foam and is exposed to the available anticoagulant powder throughout the internal pore structure of the open cell foam. In this way, the sample 12 dissolves and mixes with the dried anticoagulant powder while passing through the material 40 or open cell foam.

The open cell foam may be a blood inert, soft, deformable open cell foam, for example a melamine foam such as Basotect® foam commercially available from BASF. Alternatively, it may consist of a formaldehyde-melamine-sodium bisulfite copolymer. The open cell foam can also be a flexible, hydrophilic, open cell foam that is substantially resistant to heat and organic solvents. In one embodiment, the foam may include a sponge material.

Anticoagulants or other additives are added by soaking the foam in a solution of additive and water, followed by evaporation of the water to form a dry additive powder that is finely distributed throughout the internal structure of the foam. It may also be incorporated into open cell foams.

Collection module 14 includes a mixing chamber 22 that allows for inert mixing of blood sample 12 with an anticoagulant or another additive, such as a blood stabilizer, as blood sample 12 flows through mixing chamber 22. including. In one embodiment, mixing chamber 22 is located between inlet 32 and outlet 34.

The interior of the mixing chamber 22 may include any suitable structure or configuration so long as it provides for mixing of the blood sample 12 with the anticoagulant or other additive as the blood sample 12 passes through the passageway 36 of the collection module 14. may have.

Mixing chamber 22 receives sample 12 and sample stabilizer 24 therein and provides dispersive mixing of sample stabilizer 24 within sample 12. Mixing chamber 22 provides dispersive mixing of sample stabilizer 24 within sample 12 to prevent the sample stabilizer concentration from becoming too high in any portion of blood sample 12 . This prevents insufficient application of sample stabilizer 24 to any part of blood sample 12. Mixing chamber 22 achieves dispersive mixing of sample stabilizer 24 within sample 12 such that approximately equal amounts and/or concentrations of sample stabilizer 24 are dissolved throughout blood sample 12 . For example, approximately equal amounts and/or concentrations of sample stabilizer 24 are dissolved in the blood sample 12 from the front to the back of the blood sample 12.

In one embodiment, collection module 14 includes a collection chamber 26 disposed between mixing chamber 22 and outlet 34 . Collection chamber 26 includes an actuation section 61 . In one embodiment, the actuator 61 has a first position (FIGS. 2, 3 and 6) in which the sample 12 can be received within the collection chamber 26 and a portion of the sample 12 can be ejected from the collection chamber 26. and a second position (FIG. 7).

In one embodiment, the actuation portion 61 of the collection chamber 26 includes a first deformable portion 62, a second deformable portion 64, and a rigid portion between the first deformable portion 62 and the second deformable portion 64. Includes wall portion 66 (FIG. 8). In one embodiment, the first deformable portion 62 is located on the first side 70 of the collection chamber 26 and the second deformable portion 64 is located on the second side 72 of the collection chamber 26. Ru. In one embodiment, second side 72 of collection chamber 26 is opposite first side 70 of collection chamber 26 .

In one embodiment, the first deformable portion 62 and the second deformable portion 64 have an initial position in which the sample 12 is contained within the collection chamber 26 and a deformation in which a portion of the sample 12 is ejected from the collection chamber 26. It is possible to move between locations. The first deformable portion 62 and the second deformable portion 64 are simultaneously crushed and moved from the initial position to the deformed position.

Advantageously, by having first deformable portion 62 and second deformable portion 64 that can be simultaneously crushed, collection module 14 of the present disclosure allows more sample 12 to be removed from collection chamber 26 and outlet 34. can be distributed. Further, in one embodiment, a collection module of the present disclosure may be configured to have a first deformable portion 62 on a first side 70 and a second deformable portion 64 on an opposite second side 72. 14 has a symmetrical arrangement to provide a smooth straight flow path chamber that promotes fluid adhesion flow characteristics. The smooth straight flow path chamber of the collection module 14 does not have large geometric steps in diameter, and this smooth fluid path suppresses the formation of air pockets or bubbles.

After passing through mixing chamber 22, the stabilized sample is directed to collection chamber 26. Collection chamber 26 may take any suitable shape and size to store a sufficient amount of blood needed for the desired test, eg, 500 μl or less of blood. In one embodiment, collection chamber 26 is defined by a portion of housing 20 that is combined with first deformable portion 62 , second deformable portion 64 , and rigid wall portion 66 .

First deformable portion 62 and second deformable portion 64 may be made of any material that is flexible, deformable, and capable of providing a fluid tight seal with housing 20. In some embodiments, first deformable portion 62 and second deformable portion 64 may be made from natural or synthetic rubber or other suitable elastomeric material. The first deformable portion 62 and the second deformable portion 64 are arranged such that the first deformable portion 62 and the second deformable portion 64 are in an initial position in which the sample 12 is contained within the collection chamber 26 and a sample 12 is secured to a portion of the housing 20 such that it is movable to and from a deformed position in which the portion is ejected from the collection chamber 26.

In another embodiment, the actuation portion 61 of the collection chamber 26 may include an actuation member that applies inward pressure to the resilient portion of the actuation portion 61 to force the sample to be dispensed from the collection chamber 26. can. In this way, the sample can be transferred to equipment intended for analyzing the sample, such as point-of-care testing equipment such as cartridge testing machines, or by mouth with minimal exposure of the sample. can be transported. In certain configurations, the actuation member at least partially defines the collection chamber 26, or the actuation member is a separate element engageable with the collection chamber 26, such as a plunger, pushbutton, slide, etc. obtain. Actuating members such as those described in US Pat. can be incorporated and used in conjunction with the present invention. In other embodiments, the actuating portion 61 of the collection chamber 26 is the actuating portion and/or variations described in US Pat. may include an actuating portion according to the enabling portion, the entire disclosure of which is expressly incorporated herein by reference.

In one embodiment, collection module 14 includes a cap 30 that is removably attached to and protectively covers outlet 34 . In one embodiment, cap 30 includes a vent plug 80 that allows air to pass therethrough and prevents sample 12 from passing therethrough.

The structure of cap 30 and vent plug 80 allows air to pass through cap 30 while preventing blood sample 12 from passing through cap 30, and may include a hydrophobic filter. Vent plug 80 has a selected air passage resistance that is used to finely control the filling rate of passageway 36 and/or collection chamber 26 of collection module 14 . By varying the porosity of the vent plug, the rate of air flow from the cap 30 and, therefore, the rate of blood sample flow to the blood collection module 14 can be controlled.

In one embodiment, collection module 14 includes a closure 28 that engages inlet 32 of collection module 14 to seal passageway 36 . Closure 28 protectively covers inlet 32 . The closure 28 allows the blood sample 12 to be introduced into the passageway 36 of the housing 20 and is made of a penetrable, self-sealing material with an outer shield 84, such as the Hemogard™ cap available from Becton, Dickinson and Company. A stopper 82 may be included.

In one embodiment, collection module 14 includes a cannula 17 as part of which blood sample 12 is obtained at collection module 14 from a patient. In such embodiments, collection module 14 includes a first removable protective cap 90 and a safety shield 92.

1 and 9-12 illustrate an exemplary hinged safety shield assembly embodiment of the present disclosure. Needle assembly 5000 generally includes a needle structure 32c2 associated with hub 58c2, and a safety shield 64c2 connected to hub 58c2 and configured to shield needle structure or cannula 17 after use of the device. In one embodiment, the needle assembly 5000 may incorporate features of other known needle assemblies with hinged safety shields, such as that disclosed in US Pat. be incorporated into.

Needle structure 32c2 may include a needle portion or cannula 17 for the patient. Cannula 17 represents the patient end of needle structure 32c2 and can be beveled to define a puncture tip for puncturing the patient's skin and accessing the patient's vasculature.

Hub 58c2 may include a front hub portion 5010 and a rear hub portion 5012 through which needle structure 32c2 may be supported. In one embodiment, cannula 17 may be integral with anterior hub portion 5010 while central lumen 5006 is integral with posterior hub portion 5012. The front hub portion 5010 and the rear hub portion 5012 are configured to matingly engage. The front hub portion 5010 may include a projection 5014, such as a raised annular ring, for engaging a corresponding recess 5016 integral with the rear hub portion 5012. In another embodiment, front hub portion 5010 and rear hub portion 5012 may be joined together via adhesive or welding. When assembled, hub 58c2 defines a reverse blood indicator 60c2 therein.

Hub 58c2 may further include a collar 5018 to surround at least a portion of safety shield 64c2. In one embodiment, the front hub portion 5010 includes a first collar portion 5022 and the rear hub portion 5012 includes a second collar portion 5024. First collar portion 5022 may include a generally C-shaped region 5028 for accommodating a mounting bearing 5026 of safety shield 64c2. Mounting bearing 5026 may be integral with safety shield 64c2. The mounting bearing 5026 may also be integral with a portion of the hub 58c2, such as the first collar portion 5022 and/or the second collar portion 5024. Alternatively, the mounting bearing 5026 can be provided separately and then assembled with the safety shield 64c2 and/or the hub 58c2. First collar portion 5022 may include a protrusion 5034 for engaging a corresponding recess 5036 integral with second collar portion 5024. Thus, in one embodiment, the engagement of the front hub portion 5010 and the rear hub portion 5012 also causes the first collar portion 5022 to engage the second collar portion 5024. In another embodiment, collar 5018 is positioned substantially on the top surface of hub 58c2 to allow safety shield 64c2 to be similarly connected to the top surface of hub 58c2.

Referring to FIGS. 1 and 9, a protective cap 90 is provided over the patient's needle portion or cannula 17 prior to use, as described herein.

During use, protective cap 90 can be removed from cannula 17, thereby exposing cannula 17 for use. Cannula 17 can then engage the patient to collect a blood sample. After use, safety shield 92 is used to protectively cover and shield cannula 17, thereby preventing accidental needlestick damage.

Needle assembly 5000 can be transitioned from a retracted position, where cannula 17 is unshielded for patient access, to an extended position, where cannula 17 is safely shielded from exposure.

In some embodiments, the present disclosure accepts a sample 12 and provides flow-through blood stabilization techniques and accurate sample dispensing capabilities for use in point-of-care and near-patient testing. A biological fluid collection system 10 is provided that includes a power source 16 for a collection module 14. The power source of the present disclosure can be a user-activated vacuum source.

In one embodiment, power source 16 includes a spring-loaded device for automatically aspirating blood sample 12 within collection module 14 . The spring-loaded power source utilizes a user-actuated spring-loaded piston to create a vacuum at the distal end of collection module 14. In such embodiments, by controlling the stiffness and travel length of the springs, a predictable vacuum is applied to the fluid path of the collection module 14 and a given flow rate of blood is applied as the vacuum fills the collection module 14. can be generated. Predictable flow rates are important for mixing configurations.

4-5, in one exemplary embodiment, the power source 16 is removably connectable with the collection module 14, and the power source 16 is connected to a vacuum that draws the sample 12 into the collection chamber 26. create. In one embodiment, power source 16 includes a barrel 110, a piston 112, a spring 114, an activation button 116, and a locking device. In one embodiment, the piston 112 includes an O-ring 150 that provides a static frictional force on the inner surface of the sidewall 126 of the barrel 110.

Optionally, the power source 16 has two fixed positions, in which the piston 112 is fixed in a first piston position and a spring 114 is maintained in a compressed position, and a fixed position in which the piston 112 is unlocked and the spring 114 is in a second piston position. It may include a locking device that is transitionable between an unlocked position that can be driven into a piston position, thereby creating a vacuum that draws the sample into the collection chamber 26. Optionally, the locking device can be moved to the unlocked position by actuation of the actuation member.

Tube 110 communicates with collection chamber 26 of collection module 14 . Tube 110 defines an interior 120 and includes a first end 122, a second end 124, and a sidewall 126 therebetween. Tube 110 is removably connectable to a portion of collection module 14 . For example, in one embodiment, the barrel 110 is removably connected to the cap 30 of the collection module 14 such that the vacuum generated by the power source 16 can draw the sample 12 into the collection chamber 26 of the collection module 14. be able to. In one embodiment, cap 30 includes a vent plug 80 that allows air to pass therethrough and prevents sample 12 from passing therethrough. In this way, the vacuum created within the barrel 110 of the power source 16 is transferred to the collection module 14 such that the vacuum created by the power source 16 can aspirate the sample 12 into the collection chamber 26 of the collection module 14. collection chamber 26 .

Piston 112 is slidably disposed within interior 120 of cylinder 110 . Piston 112 is sized relative to interior 120 of barrel 110 for sealing engagement with sidewall 126 of barrel 110 . The piston 112 has a first piston position (FIG. 4) in which the piston 112 is a first distance from the first end 122 of the barrel 110 and a first piston position (FIG. 4) in which the piston 112 is a first distance from the first end 122 of the barrel 110. and a second piston position (FIG. 5) that is a second distance greater than the distance .

4-5, spring 114 is disposed between first end 122 of barrel 110 and piston 112. Referring to FIGS. In one embodiment, activation button 116 is located on a portion of barrel 110.

Power source 16 also includes a locking device that connects with spring 114 and activation button 116 . The locking device has two positions, one in which the locking device locks piston 112 in a first piston position (FIG. 4) and maintains spring 114 in a compressed position, and the other in which the locking device locks piston 112 in a first piston position (FIG. 4) and maintains spring 114 in a compressed position. piston position (FIG. 5), thereby creating a vacuum that pulls the sample 12 into the collection chamber 26 of the collection module 14. In one embodiment, actuation of activation button 116 transitions the locking device to the unlocked position.

Advantageously, the collection module and power source of the present disclosure can engage many different power sources through which biological fluids, such as blood sample 12, pass. For example, in some embodiments, the collection module and power source of the present disclosure can engage a conventional tube holder. In other embodiments, the user-activated power source of the present disclosure allows a user to connect directly to a luer line, such as an IV catheter, wingset, PICC, or similar device. In other embodiments, when the collection module and power source are used with a HemoLuer, the user can attach the collection module and power source to a Luer (by removing the HemoLuer) or a conventional tube holder (by interfacing with the HemoLuer). You can connect to either. Advantageously, the system of the present disclosure also allows direct luer access without the use of a LLAD (luer line access device) or any other holder.

In one embodiment, collection module 14 includes a cannula 17 as part of which blood sample 12 is obtained from the patient into collection module 14 . In such embodiments, collection module 14 includes a first removable protective cap 90 and a safety shield 92. In such embodiments, cannula 17 can be engaged with the patient and power source 16 can then be used to create a vacuum that draws sample 12 into collection chamber 26.

In one embodiment, blood sample 12 is drawn into passageway 36 of housing 20 in collection module 14 by suction due to a vacuum created within the barrel. In one embodiment, the blood sample 12 fills the entire passageway 36 such that when the blood sample 12 enters the collection module 14, the blood sample 12 passes through an open cell foam, e.g. The body's internal pore 42 structure is exposed to available anticoagulant powder. In this manner, the sample 12 dissolves and mixes with the dried anticoagulant powder while passing through the material 40 or open cell foam. Mixing chamber 22 then receives sample 12 and sample stabilizer 24 therein to achieve dispersive mixing of sample stabilizer 24 within sample 12. After passing through mixing chamber 22, the stabilized sample is directed to collection chamber 26. Collection chamber 26 may take any suitable shape and size to contain a sufficient amount of blood, eg, 500 μl or less, required for the desired test. In one embodiment, cap 30 stops collecting blood sample 12 once passageway 36, mixing chamber 22, and collection chamber 26 of collection module 14 are completely filled. Vent plug 80 in cap 30 allows air to pass through cap 30 while preventing blood sample 12 from passing through cap 30 and into barrel 110 of power source 16 .

In one embodiment, power source 16 is separated from collection module 14 once sample collection is complete. Once the collection module 14 is separated from the power source 506, the cap 30 can then be removed from the collection module 14 to expose the outlet 34 of the housing 20 on the collection module 14. Removal may be accomplished by the user grasping the outer portion of the cap 30 and pulling the cap 30 from the housing 20. Blood sample 12 is retained within passageway 36 of housing 20, eg, within collection chamber 26, by capillary action after removal of cap 30.

Blood sample 12 may then be dispensed from collection module 14 by activating actuator 61 . In one embodiment, the actuation portion 61 includes a first deformable portion 62 and a second deformable portion 64. By way of example, the first deformable portion 62 and the second deformable portion 64 may be configured to have an initial position in which the sample 12 is received within the collection chamber 26 and a position in which a portion of the sample 12 is ejected from the collection chamber 26 and the outlet 34. and the deformed position. The first deformable portion 62 and the second deformable portion 64 are simultaneously crushed and moved from the initial position to the deformed position. In this way, the blood sample 12 is transferred to a device intended to analyze the sample, such as a point-of-care test device 105 (FIG. 6), a cartridge test device, etc., while minimizing exposure of the physician to the blood sample. It can be transferred to a machine or to a testing device near the patient.

Advantageously, the collection module 14 of the present disclosure collects more sample 12 from the collection chamber 26 and outlet 34 by having first deformable portion 62 and second deformable portion 64 that can be simultaneously crushed. can be distributed. Further, in one embodiment, the collection module 14 of the present disclosure has a first deformable portion 62 on a first side 70 and a second deformable portion 64 on an opposite second side 72. Thus, the collection module 14 of the present disclosure has a symmetrical arrangement to provide a smooth straight channel chamber that promotes fluid adhesion flow characteristics.

The present disclosure provides a power source for a collection module 14 that accepts a sample 12 and provides flow-through blood stabilization technology and accurate sample dispensing capabilities for use in point-of-care and near-patient testing. A biological fluid collection system 10 is provided that includes 16. The power source of the present disclosure can be a user-activated vacuum source.

The power source 16 of the present disclosure is disclosed in US Pat. Power source systems may be included in accordance with other power source systems described.

As described herein, the present disclosure provides sample-accepting, flow-through blood stabilization technology and accurate sample dispensing capabilities for point-of-care and near-patient testing applications; A biological fluid collection system is provided that includes a power source for a collection module comprising. The power source of the present disclosure includes a user-activated vacuum source for aspirating the biological fluid sample within the collection module.

The collection module of the present disclosure can provide dispersive mixing of a sample stabilizer within a blood sample and dispense the stabilized sample in a controlled manner. In this way, the biofluid collection system of the present disclosure is useful for blood microsample management, e.g., inert mixing with sample stabilizers and controlled distribution.

Advantageously, the biofluid collection system of the present disclosure is useful for point-of-care and near-patient testing applications, automated blood collection, inert mixing techniques, and point-of-care cartridges and near-patient testing. Provides a consistent blood sample management tool for controlled small volume sample dispensing capabilities to standard Luer interfaces with 2 inlets.

13-14, a biological fluid collection device 10 of the present disclosure is configured to receive a biological fluid sample, such as a blood sample 12, and includes a collection module 14 and an external body removably connectable to the collection module 14. housing 16a. In one embodiment, collection module 14 is disposed within outer housing 16, as shown in FIGS. 13-14, with collection module 14 connected to outer housing 16a. The outer housing 16a may be a vacuum-containing blood collection tube, such as a Vacutainer® blood collection tube available from Becton, Dickinson and Company.

In one embodiment, collection module 14 is disposed within outer housing 16a and is compatible with tube holder 102 having a cannula and wingset 104. In use, the needle cannula of the tube holder 102 is inserted into the passageway 36 of the housing 20 of the collection module 14 through the inlet 32, such as the penetrable self-sealing stop 82 of the closure 28. Biological fluid collection device 10, including composite collection module 14 and outer housing 16, may be inserted into a conventional tube holder 102 having a cannula through which biological fluid, such as blood sample 12, passes.

Blood sample 12 is drawn from conventional tube holder 102 into passageway 36 of housing 20 of collection module 14 by drawing a vacuum contained in outer housing 16a. In one embodiment, the blood sample 12 fills the entire passageway 36 such that when the blood sample 12 enters the collection module 14, the blood sample 12 passes through an open cell foam, e.g. The body's internal pore 42 structure is exposed to available anticoagulant powder 44 . In this manner, the blood sample 12 dissolves and mixes with the dried anticoagulant powder 44 while passing through the material 40 or open cell foam. Mixing chamber 22 then receives sample 12 and sample stabilizer 24 therein, providing dispersive mixing of sample stabilizer 24 within sample 12. After passing through mixing chamber 22, the stabilized sample is directed to collection chamber 26. Collection chamber 26 may take any suitable shape and size to accommodate a sufficient amount of blood needed for the desired test, eg, 500 μl or less. In one embodiment, cap 30 stops collecting blood sample 12 once passageway 36, mixing chamber 22, and collection chamber 26 of collection module 14 are completely filled. Vent plug 80 in cap 30 allows air to pass through cap 30 while preventing blood sample 12 from passing through cap 30 and into outer housing 16 .

In one embodiment, upon completion of sample collection, the outer housing 16a containing the collection module 14 is separated from the tube holder 102, and the outer housing 16a then removes the closure 28, which is still attached to the collection module 14, to the outside. It is separated from collection module 14 by removal from housing 16a. Removal of closure 28 may be accomplished by a user grasping both outer shield 84 and outer housing 16 of closure 28 and pulling or twisting them in opposite directions.

Once the collection module 14 is separated from the outer housing 16a, the cap 30 can then be removed from the collection module 14 to expose the outlet 34 of the housing 20 on the collection module 14. Removal may be accomplished by the user grasping the outer portion of the cap 30 and pulling the cap 30 from the housing 20. Blood sample 12 is retained within passageway 36 of housing 20, eg, within collection chamber 26, by capillary action after removal of cap 30. In one embodiment, removal of cap 30 may alternatively occur when removing collection module 14 from outer housing 16. In this configuration, cap 30 is constrained within outer housing 16. In one embodiment, engaging cap 30 with outer housing 16 may allow outer housing 16 and cap 30 to be removed in a single step.

Blood sample 12 may then be dispensed from collection module 14 by actuating first deformable portion 62 and second deformable portion 64 . For example, first deformable portion 62 and second deformable portion 64 may be configured to have an initial position in which sample 12 is contained within collection chamber 26 and a position in which a portion of sample 12 is ejected from collection chamber 26 and outlet 34. It is possible to move between the deformed positions. The first deformable portion 62 and the second deformable portion 64 are simultaneously crushed and moved from the initial position to the deformed position. In this way, the blood sample 12 is transferred to a device intended to analyze the sample, such as a point-of-care test device 105 (FIG. 6), a cartridge test device, etc., while minimizing exposure of the physician to the blood sample. It can be transferred to a machine or to a testing device near the patient.

The present disclosure includes a blood collection device for collecting arterial blood samples using radial stick technology. The present disclosure streamlines and reduces the number of workflow steps that are critical in arterial blood gas (ABG) collection procedures. The proposed device includes automatic anticoagulant mixing and integrated venting to evacuate air bubbles during collection.

Existing ABG syringes typically use a conventional hypodermic needle with a safety shield that must be snapped or slid over the needle after blood is drawn. These safety guards are often in line of sight during the blood collection process, obscuring the physician's view during this delicate process. Conventional ABG syringes also often have a separate vent cap that requires the needle to be removed before attaching the cap to the syringe to vent trapped air bubbles from the collected sample. The anticoagulant is typically filled into the ABG syringe, and the user must roll or shake the collected sample to thoroughly mix it with the anticoagulant. The disclosed device has the following advantages over conventional arterial blood gas (ABG) collection kits. (1) Ergonomic design with designated contact points. (2) Thin-walled needle technology (Becton's Ultra touch). (3) A push-button safety shield that does not obstruct the user's view during the procedure and can be activated with one hand by simply pressing a button after collection. (4) Integrated vent/vent cap feature that can remove trapped air bubbles by easily draining during filling or after collection. and (5) use of a safety sleeve with a guard and pushbutton to prevent accidental activation of the safety shield during transportation of the device.

In another concept of the present disclosure, referring to FIGS. 15-27, body fluid collection assembly 10b generally includes a needle assembly 11b, a first needle shield 60b, a tube holder 13b, and a body fluid collection cartridge 20b. According to one embodiment, body fluid collection assembly 10b may include an arterial blood collection assembly. Although described herein with respect to arterial blood collection cartridge 20b intended for use with needle assembly 11b, the cartridge 20b of the present disclosure may include a separate needle that includes a puncturing element or allows for attachment to a catheter or arterial line. may be used with or incorporated with other medical devices, such as medical device assemblies.

In the exemplary embodiment, the main components of body fluid collection cartridge 20b include a plunger assembly 30b having a removable plunger rod 31b and a stopper 32b that slidably couples with tubular member 21b and closure 40b. include.

15-18, in one exemplary embodiment, body fluid collection cartridge 20b includes a proximal end 23b, an open distal end 22b, and a sidewall extending between proximal end 23b and distal end 22b. 25b and includes an elongated hollow cylindrical tubular member 21b defining an internal chamber 26b having an internal reservoir 28b. Sidewall 25b of tubular member 21b defines an interior surface 27b for slidably receiving plunger assembly 30b. An annular flange 24b is provided at the proximal end 23b of the tubular member 21b and extends from the inner surface 27b into the chamber 26b to partially close the proximal end 23b of the tubular member 21b.

Tubular member 21b may be made of one or more representative materials of polypropylene, polyethylene, polyethylene terephthalate (PET), polystyrene, polycarbonate, cellulose, glassware, or combinations thereof. More expensive plastics such as polytetrafluoroethylene and other fluorinated polymers can also be used. In addition to the materials listed above, examples of other suitable materials include polyolefins, polyamides, polyesters, silicones, polyurethanes, epoxies, acrylics, polyacrylates, polysulfones, polymethacrylates, PEEK, polyimides, and PTFE Teflon. , FEP Teflon®, Tefzel®, poly(vinylidene fluoride), PVDF, and fluoropolymers such as perfluoroalkoxy resins. One exemplary glass product is PYREX® (available from Corning Glass, Corning, NY). According to embodiments of the invention, a ceramic collection device may be used. According to the present disclosure, cellulosic products such as paper and reinforced paper containers can also be used to form collection devices.

15-18, in one exemplary embodiment, body fluid collection cartridge 20b also includes a plunger assembly 30b slidably received within a chamber 26b defined by sidewall 25b of tube 21b. Plunger assembly 30b includes a stopper 32b and a removable plunger rod 31b. Stopper 32b is slidably disposed in liquid-tight engagement with inner surface 27b and can slide distally and proximally along longitudinal axis 29b. Stopper 32b and plunger rod 31b are removably associated with each other by an interengaging arrangement 90b. Interengaging configuration 90b allows plunger rod 31b to apply a distal force against stopper 32b, and also allows a proximal force to be applied, as indicated by "P" in FIG. When the plunger rod 31b is removed from the stopper 32b and the tubular member 21b, the plunger rod 31b is configured to be able to be removed from the stopper 32b and the tubular member 21b. In other words, stopper 32b and plunger rod 31b are not mechanically fixed to each other, but in a removable connection configuration that only allows plunger rod 31b to apply a force distally to stopper 32b. It is just placed. The proximal end of the removable plunger rod 31b can be used by the user to apply a force pushing the entire plunger assembly 30b distally or pulled to remove the plunger rod 31b from the tubular member 21b. It can include a thumb flange 33b that can be used.

Referring to FIGS. 15-18, in one exemplary embodiment, stopper 32b includes a distal surface 34b and a proximal surface 35b. The diameter of stopper 32b is approximately equal to or slightly less than the inner diameter "a" of tube 21b, but greater than the inner diameter "b" of annular flange 24b. Stopper 32b is in slidable contact with inner surface 27b of tube 21b to provide a fluid-tight seal between plunger assembly 30b and inner surface 27b of tube 21b such that the sample is at the distal end of tube 21b. 22b and the distal face 34b of stopper 32b is retained within an internal reservoir 28b formed within chamber 26b to prevent sample from leaking out of proximal end 23b of tube 21b.

Stopper 32b is a low-resistance stopper and, as such, is designed to have relatively low frictional resistance to movement within tube 21b when compared to similar components of conventional arterial blood gas syringes, thereby reducing internal reservoir 28b. Due to the presence of fluid pressure, such as arterial blood pressure, within the proximal end of tube 21b, stopper 32b is forced into contact with the proximal end of tube 21b until proximal surface 35b of stopper 32b contacts annular flange 24b, thereby limiting proximal movement of stopper 32b. 23b in a proximal direction. The frictional resistance of the stopper can be reduced by a combination of either the design of the profile and/or the selection of materials of construction for the sealing of the stopper. A first sealing ring 36b and a second sealing ring 37b extend around the outer circumferential surface of stopper 32b, proximate distal surface 34b and proximal surface 35b, respectively, and are in primary contact with inner surface 27b of tube 21b. Create a secondary seal. This stopper sealing profile design reduces the amount of contact between the stopper 32b and the inner surface 27b, thereby providing more friction against movement of the stopper 32b compared to a stopper sealing profile in which the entire outer circumferential surface contacts the inner surface 27b. Reduce resistance. Alternatively, or in combination with the stopper sealing profile design, the stopper 32b is preferably made of natural rubber, synthetic rubber, thermoplastic elastomers, and those compounded or synthesized to be self-lubricating or have relatively low frictional resistance. Made of elastomeric materials such as a combination of. Stopper 32b may also be made from an elastomeric combination including a harder inner rubber core and an outer layer of soft, self-lubricating polymeric material. Self-lubricating polymeric materials have a lubricant such as silicone oil incorporated into the polymeric material, one example of which is Epirol.

Before use, plunger rod 31b contacts proximal surface 35b of stopper 32b such that plunger rod 31b can only apply a force acting in the distal direction. The interengaging arrangement 90b can include a male member such as a conical finger 39b extending from the distal end of the plunger rod 31b, the male member having a conical shape at the proximal surface 35b of the stopper 32b. It is configured to mate with a corresponding female member such as recess 45b. It is understood that conical fingers 39b and conical recesses 45b illustrate one example of an interengaging configuration 90b, and that other interengaging configurations may be used to removably connect plunger rod 31b to stopper 32b. can be done. For example, interengaging arrangement 90b may be designed such that the distal end of plunger rod 31b includes a female member configured to mate with a corresponding male member extending from proximal surface 35b of stopper 32b. Can be done.

20-22, by applying a force to thumb flange 33b, such as by a user, plunger rod 31b transmits the applied force to move stopper 32b in a distal direction, causing distal end of tube 21b. If there is a liquid passageway in distal end 22b, it forces liquid out of the blood collection cartridge. However, pulling plunger rod 31b proximally, as indicated by "P" in FIG. 22, exerts no force on stopper 32b. Since the conical finger 39b is only withdrawn from contact with the recess 45b, the stopper 32b remains stationary within the tube 21b while the plunger rod 31b is removed from the tubular member 21b.

Plunger rod 31b is desirably constructed of a suitable polymeric material and can be manufactured by injection molding using suitable polymeric materials known in the art. It is within the scope of the invention to include plunger rods and stoppers, which may be formed separately or integrally, of the same material or different materials, such as two-color molding, or which may be the same or different. Separately formed of materials and joined by mechanical means, adhesives, ultrasonic welding, heat sealing, or other suitable means.

Referring to FIGS. 15-18, in one exemplary embodiment, a penetrable closure 40b is associated with the open distal end 22b of the tubular member 21b. Closing portion 40b is configured to cooperate with sidewall 25b of tubular member 21b to sealingly close open distal end 22b to form a liquid-impermeable seal for containing a bodily fluid sample. . Closure 40b includes an outer end 41b and an inner end 42b structured to be at least partially received within tubular member 21b. The portion of closure 40b adjacent open distal end 22b of tube 21b defines a maximum outer diameter that exceeds the inner diameter "a" of tube 21b. The inherent elasticity of the closure 40b can ensure a sealing engagement with the inner surface 27b of the wall 25b of the tube 21b. The portion of closure 40b extending downwardly from inner end 42b has a diameter ranging from a small diameter approximately equal to or slightly less than the inner diameter "a" of tube 21b adjacent to distal end 22b. Can taper to a large diameter. Thus, the inner end 42b of the closure 40b may be pushed into the portion of the tube 21b adjacent the distal open end 22b. Closure 40b is such that it can be penetrated by needle 50b or other cannula to introduce a biological sample into tubular member 21b. According to one embodiment, closure 40b is resealable. The closure 40b may also be formed to define a cavity 43b extending within the interior end 42b, as shown in FIG. 19. Cavity 43b may be sized to receive at least a corresponding mixing fin 44b extending distally from distal face 34b of stopper 32b. Alternatively, there may be multiple cavities and corresponding mixing fins. Suitable materials for closure 40b include, for example, silicone rubber, natural rubber, styrene butadiene rubber, elastomers such as ethylene-propylene copolymers and polychloroprene, thermoplastic elastomers, and the like.

According to one embodiment, body fluid collection cartridge 20b may include additional additives necessary for a particular test procedure, such as anticoagulants, clotting agents, stabilizing additives, etc., as shown as 70b in FIG. 19. . Such additives may be sprayed onto the inner surface 27b of tube 21b or placed within internal reservoir 28b. Anticoagulants can include hirudin, hirudin derivatives, chelating agents, or chelating agent derivatives. Particular anticoagulants include citrate, ethylenediaminetetraacetic acid (EDTA), heparin, CPAD, CTAD, CPDA-1, CP2D, potassium oxalate, sodium fluoride, or ACD. Anticoagulants can be used in liquid form to improve contamination and thus improve the effectiveness of anticoagulants during arterial blood collection. The liquid form can be an emulsion, solution, or dispersion of the anticoagulant in a suitable carrier. Other known arterial blood sample collection methods use arterial blood gas syringes that are preloaded during manufacture with a solid form of anticoagulant, such as heparin powder, in the syringe barrel to maximize the shelf life of the syringe. do. The use of solid anticoagulants can reduce the effectiveness of the anticoagulant because it is difficult to incorporate powdered heparin into the blood sample due to lack of agitation during the arterial blood collection process.

The combination of the cavity 43b in the interior end 42b of the closure 40b and the mixing fins 44b extending from the distal surface 34b of the stopper 32b provides an asymmetrical surface at each end of the fluid reservoir 28b. Referring to FIGS. 25-26, when cartridge 20b is rotated by rotating the cartridge about a longitudinal axis in the direction of arrows w and Generate a vortex to promote thorough mixing. This is particularly useful when there is no air (headspace) in the liquid reservoir of the collection vessel. Especially when the contents are of similar density, even if such a device is turned upside down, there is little mixing of the contents. Containers with cylindrical internal liquid reservoirs, such as pill bottles, insulin pen cartridges, and syringes, typically have flat interior surfaces at the top and bottom of the liquid reservoir. Therefore, little turbulence occurs when these containers roll.

15-22, an embodiment of a body fluid collection system is shown that includes a needle assembly 11b and a holder 13b. Needle assembly 11b includes a needle cannula 50b having a pointed proximal end 51b, a pointed distal end 52b, and a lumen 53b extending between the proximal end 51b and the distal end 52b. Needle assembly 11b further includes a hub 54b having a proximal end 55b, a distal end 56b, and a passageway extending between the proximal end 55b and the distal end 56b. A portion of needle cannula 50b extending between proximal end 51b and distal end 52b is securely attached to the passageway of hub 54b. In this manner, the sharp proximal end 51b of needle cannula 50b projects proximally beyond hub 54b, and the sharp distal end of the needle cannula projects distally beyond hub 54b. An external surface area of hub 54b near proximal end 55b of hub 54b may be formed with an attachment structure, such as an externally threaded arrangement, at least one annular groove, or at least one annular rib. This attachment structure allows needle hub 54b to be secured to holder 13b that is configured to slidably receive blood collection cartridge 20b according to an embodiment of the present disclosure. Needle assembly 11b may further include a plurality of sample sleeves 57b attached to the proximal portion of needle cannula 50b and secured to proximal end 55b of hub 54b, as shown in FIG. 19. When hub 54b of needle assembly 11b is attached to holder 13b, the proximal portion of needle cannula 50b and plurality of sample sleeves 57b protrude into holder 13b.

Referring to FIGS. 15-22, in the exemplary embodiment, needle assembly 11b includes a first needle shield 60b and a second needle shield 61b. A first needle shield 60b covers the distal end 52b of the cannula 50b and a second needle shield 61b covers the proximal end 51b of the cannula 50b. The first needle shield 60b includes an indicator tip 62b at the distal end that is activated by the presence of a liquid treatment material 70b, such as a liquid anticoagulant.

Assembly of body fluid collection cartridge 20b is accomplished by slidably inserting stopper 32b into chamber 26b through distal end 22b of tubular member 21b. A liquid treatment material 70b, such as the liquid anticoagulant heparin, is then added to the fluid reservoir 28b before the distal end 22b is sealed by insertion of the closure 40b. Plunger rod 31b is then inserted through annular flange 24b at proximal end 23b of tube 21b until conical finger 39b engages recess 45b. The assembly can be packaged for later use.

In a method of use according to one embodiment of the invention, second needle shield 61b is removed from needle assembly 11b and holder 13b is connected to needle assembly 11b for body fluid collection, such as arterial blood collection. Next, a body fluid collection cartridge 20b according to an embodiment of the invention, such as a blood collection cartridge, is inserted into the tube, with the pointed proximal end 51b of the needle 50b passing through the closure 40b, as shown in FIGS. 19-21. The proximal end of holder 13b is inserted until cavity 53b is in fluid communication with a liquid handling material 70b, such as liquid heparin anticoagulant, located in fluid reservoir 28b.

The user then grasps the holder 13b, fixes his fingers around the outwardly extending annular flange 15b on the holder 13b, and applies sufficient force to the thumb flange in the distal direction "D" as shown in FIG. 33b, and this depression causes the distal surface of stopper 32b to contact interior end 42b of closure 40b, internal mixing fins 44b to engage recess 45b, and to push down near cannula 50b, as shown in FIG. This is continued until the distal end 51b is accommodated in the cavity 43b of the stopper 32b. This operation causes liquid treatment material 70b in body fluid collection cartridge 20b to flow from liquid reservoir 28b through proximal end 51b into lumen 53b of cannula 50b and into first needle shield 60b. The indicator tip 62b becomes activated and changes color upon contact with excess fluid treatment material as it exits the distal end 52b of the needle 50b, causing the indicator tip 62b to activate and change color when it comes into contact with excess fluid treatment material as it is expelled from the distal end 52b of the needle 50b. Provide the user with visual confirmation that any dead spaces are filled with fluid treatment material 70b. Plunger rod 31b can then be separated from stopper 32b by pulling plunger rod 31b in a proximal direction (indicated by arrow P), as shown in FIG. 22. The residual volume (10-20 μl) of liquid treatment material 70b present in the dead space must be at such a concentration that it provides sufficient treatment, such as providing sufficient anticoagulation to prevent clotting of the arterial blood sample upon collection. No.

The purpose of filling assembly 10b with liquid treatment material is to exclude atmospheric air so that the partial pressure of oxygen, such as in an arterial blood sample, is not affected by atmospheric air. Assembly 10b should preferably have a small dead space to keep the residual volume of the fluid treatment material low to minimize the dilution effect of the fluid treatment material on the body fluid sample.

The method of body fluid collection according to one embodiment of the present invention allows a one-handed technique similar to current clinical practice in body fluid collection processes or arterial blood collection processes using low resistance rubber stoppers driven by arterial pressure. First needle shield 60b is removed from needle assembly 11b. The user grasps the assembly 10b with one hand and inserts the distal end 52b into a fluid source, such as a patient's artery, as shown in FIG. 23. When moving arterial blood using the present invention, blood at arterial pressure (greater than normal atmospheric or ambient pressure) flows through lumen 53b of cannula 50b into fluid reservoir 28b and displaces stopper 32b in a proximal direction. until the stopper proximal surface 35b contacts the annular flange 24b, as shown in FIG. 24, thereby indicating that the amount of blood sample to be collected has been collected. be exposed. The sliding movement of the rubber stopper 32b allows mixing of the liquid handling material 70b and the collected arterial blood, as shown at 47b, during the collection process.

The liquid or blood collection cartridge 20b is then removed from the multi-sample needle assembly 11b and holder 13b. Distal end 52b can then be removed from the fluid source or artery. The separated cartridge 20b is then moved between the user's hands in a plane perpendicular to the longitudinal axis 29b to further mix the body fluid sample with a liquid treatment material 70b, such as heparin, as shown in FIGS. 25-26. You can also roll it between your palms. The asymmetrical finned surfaces of the interior end 42b of the closure 40b and the distal surface 34b of the stopper 32b create a vortex when the cartridge 20b is rotated in the directions indicated by arrows w, x, y, and z. The body fluid collection cartridge 20b containing the body fluid sample is now ready for transport to a laboratory, such as for arterial blood gas analysis.

According to one embodiment, a Luer adapter 80b as shown in FIG. 27 is then inserted through the closure 40b of the cartridge 20b such that the cartridge is provided with an interface connection compatible with a blood gas analyzer. Can be done. A variety of different Luer adapters may be provided to allow the body fluid collection cartridge 20b to connect to all different types of testing devices and/or all different types of blood gas analyzer interfaces. Luer adapter 80b may also include a luer tip cap (not shown) to seal body fluid collection cartridge 20b when luer adapter 80b is connected.

Referring to FIGS. 15 and 28-30, in one embodiment, the device can also include a shieldable needle device 12. For example, referring to FIGS. 15 and 28-30, the liquid fluid collection assemblies 10b, 10c can include a shieldable needle device 12c.

In one exemplary embodiment, the shieldable needle device 12c includes a flexible tube 14c extending from the needle device 12c, a fixture 16c attached to the flexible tube 14c, a needle cannula 20c, a hub 30c, and an external A shield 50c may be included. In some embodiments, fixture 16c can be connected to a container (not shown) for use in blood collection procedures, as is known in the art.

In one embodiment, needle cannula 20c includes a proximal end and an opposite distal end, and lumen 26c extends through needle cannula 20c from the proximal end to the distal end. The distal end of needle cannula 20c is beveled to define a sharp puncture tip 28c, such as an intravenous puncture tip. Puncture tip 28c is provided for insertion into a patient's blood vessel, such as a vein, and is therefore designed for ease of insertion and minimal discomfort during venipuncture. Before using blood collection set 10c, a removable protective cover (not shown) can be placed over the distal end of needle cannula 20c to protect from puncture tip 28c.

Shieldable needle device 12c further includes a hub 30c. Hub 30c is of unitary construction, preferably molded from a thermoplastic material. Needle cannula 20c is disposed within and supported by the internal passageway of hub 30c, with a distal end of needle cannula 20c extending from the distal end of hub 30c. Desirably, needle cannula 20c and hub 30c are separate parts that are fixedly attached and secured, such as by a suitable medical grade adhesive. The proximal end of hub 30c is adapted for connection with flexible tubing 14c of blood collection set 10c. Hub 30c further includes a first tab 40c extending outwardly from the outer surface adjacent the proximal end of hub 30c. In this manner, flexible tab 40c is accessible to a user's finger when shieldable needle device 12c is assembled with tube 14c within blood collection set 10c.

Shieldable needle device 12c further includes a hollow outer shield 50c. Outer shield 50c further includes a second tab 62c extending outwardly from the top of housing 50c. The second tab 62c includes an angled surface having a protrusion thereon to provide frictional engagement with the user's thumb.

Outer shield 50c is configured in a retracted position in which first tab 40c is exposed from the proximal end of outer shield 50c and puncture tip 28c is exposed from the distal end of outer shield 50c, and in a retracted position in which puncture tip 28c and needle cannula 20c are distal. It is movable between an extended position and an extended position where the ends are covered by outer shield 50c.

The first tab 40c and the second tab 62c cause the outer shield 50c to move toward the distal end of the needle cannula 20c by opposing forces applied to the first tab 40c and the second tab 62c. It is configured to move from a contracted position to an extended position in the direction of arrow 100c. The protrusions on the first tab 40c and the second tab 62c provide frictional engagement with a user's finger and thumb, respectively, to facilitate moving the outer shield 50c from the retracted position to the extended position.

Outer shield 50c may further include a pair of stabilizers in the form of wings 68c extending laterally from outer shield 50c on opposite sides of each other, providing blood collection set 10c as a butterfly-type wing assembly. Wings 68c assist in positioning and placing shieldable needle device 12c and blood collection set 10c during a blood collection procedure and are configured to lie flat against the surface of the patient's skin during the blood collection procedure. Accordingly, the wings 68c are such that at least one, and preferably both, of the wings 68c are bent toward each other and brought together between the user's fingers to assist in positioning and placing the shieldable needle device 12c during venipuncture. It may be constructed of flexible material to allow for.

The shieldable needle device 12c can be packaged substantially as shown in FIGS. 15 and 28. In particular, blood collection set 10c includes a needle assembly 12c that is assembled and includes a flexible tube 14c extending from needle assembly 12c and connected to a fixture 16c. Before use, blood collection set 10c is removed from the package. After removing the blood collection set 10c from its packaging, it can be used in conjunction with other suitable medical equipment. Fixture 16c can then be connected to a suitable container, such as a non-patient needle assembly or needle holder, to provide fluid communication with lumen 26c through needle cannula 20c.

To prepare blood collection set 10c for use, a user grasps blood collection set 10c at shieldable needle device 12c and removes a protective cover (not shown) to expose puncture tip 28c of needle cannula 20c. The physician can then push puncture tip 28c at the distal end of needle cannula 20c into the patient's desired blood vessel. During such positioning, at least one of the wings 68c may be bent inwardly toward the other by the user's finger to facilitate positioning and installation of the shieldable needle device 12c. Once the procedure is complete, such as when all necessary samples have been taken, needle cannula 20c is withdrawn from the patient. After removing the needle cannula 20c from the patient, activation of the safety feature of the shieldable needle device 12c is realized.

Although this disclosure has been described as having an exemplary structure, this disclosure can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Furthermore, this application is intended to cover any departures from this disclosure that are within the known or practice of the art to which this disclosure pertains and which fall within the scope of the appended claims. Ru.

Claims (8)

a collection module configured to accept a sample;
a housing having an inlet and an outlet, the inlet and outlet being in body fluid communication;
cannula and
a mixing chamber disposed between the inlet and the outlet;
a collection chamber disposed between the mixing chamber and the outlet, the collection chamber including a first deformable portion disposed on a first side of the collection chamber; a second deformable portion disposed on a second side of the collection chamber opposite the first side, wherein the first deformable portion and the second deformable portion are arranged such that the sample a collection chamber transitionable between a first position in which the sample is accommodated within the collection chamber and a second position in which a portion of the sample is ejected from the collection chamber;
a collection module including;
the safety shield is movable from a first position in which a portion of the cannula is exposed to a second position in which the cannula is shielded by at least a portion of the safety shield;
A biological fluid collection system comprising: The biological fluid collection system of claim 1, wherein the collection module further includes a hub connected to the cannula, and the safety shield is pivotally engaged with the hub. The biological fluid collection system of claim 1, further comprising a tip cap disposed on at least a portion of the outlet. The biological fluid collection system of claim 1, wherein the mixing chamber further includes a sample stabilizer disposed therein. 5. The biological fluid collection of claim 4, wherein the mixing chamber further comprises an open cell foam having pores, and the sample stabilizer is disposed within the pores of the open cell foam. system. 6. The biological fluid collection system of claim 5, wherein the open cell foam is melamine foam. 2. A sample according to claim 1, wherein a sample is withdrawn from a patient through the cannula into the mixing chamber, and the sample is passively mixed with a sample stabilizer before entering the collection chamber. A biological fluid collection system as described. The mixing chamber includes an open cell melamine foam, and the sample stabilizer is disposed within the pores of the open cell melamine foam and passively interacts with the sample stabilizer as the sample passes through the open cell melamine foam. 8. The biological fluid collection system according to claim 7, wherein the biofluid collection system is mixed together.

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